FDA 510(k)
FDA class 2
Substantially Equivalent
🇺🇸 United States
Alinity h-series System
K Number: K220031
·
Decision Aug 4, 2023
Classifications
1
FEI Numbers
62
Registration Numbers
62
Same Product Code
379
Applicant Total
883
Review Days
576
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Basic Information
- Device Name
- Alinity h-series System
- K Number
- K220031
- Device Class
- FDA class 2
- Clearance Type
- Traditional
- Regulation Number
- 864.5220
- Medical Specialty
- Hematology
- Decision
- Substantially Equivalent
- Statement or Summary
- Summary
- Applicant
- Abbott Laboratories
- Date Received
- January 5, 2022
- Decision Date
- August 4, 2023
- Product Code
- GKZ
- Advisory Committee
- Hematology
- Review Advisory Committee
- HE
- Third Party
- N
Classifications
This FDA 510(k) entry is associated with 1 FDA classification via its product code.
| Product Code | Device Name | Device Class | Medical Specialty |
|---|---|---|---|
| GKZ | Counter, Differential Cell | FDA class 2 | Hematology |
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